NCT06239493

IVUS-Guided Treatment for Percutaneous Vascular Interventions

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to survey and improve the IVUS image quality and X-ray system interoperability by collecting Procedural Data (e.g. raw, pre- processed ultrasound and X-ray data, endpoints such as fluoroscopy time, contrast load and radiation dose, workflow details) during routine intravascular procedures to assure adherence to the high standards of quality during care delivery and promote procedural standardization.

Detailed description

This is a prospective, multicenter, single-arm study to collect procedural data (e.g., raw, pre-processed IVUS, X-ray, and other procedural data) for image quality, workflow and interoperability assessments. Example of additional procedural endpoint data (e.g., time for fluoroscopy and IVUS, contrast load and radiation dose, workflow details, etc.) will be collected. The study will be conducted in a phased approach. Since the collection of IVUS raw data with a second non-diagnostic pullback affects procedure time, the two aspects of this study - collection of raw IVUS data and procedural data, will be separated until IVUS raw data can be collected directly from the IVUS system with no additional procedural time.

Conditions

• CAD
• PAD
• DVT

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	IVUS Guided	Those already undergoing an IVUS guided percutaneous vascular intervention

Timeline

• Start date: 2023-09-14
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2024-02-02
• Last updated: 2025-05-31

Locations

5 sites across 1 country: United States